Kornimate/medical-research-clean huggingface dataset:
co-administration of ivm and alb in school-based deworming in uganda

Conditions: Helminthiasis; Intestinal Worms

Summary: the goal of this small-scale implementation research pilot study is to assess the feasibility and acceptability of the co-administration of ivermectin (ivm) and albendazole (alb) compared to albendazole alone during school-based mass drug administration in uganda. the study will target up to 10,000 school-aged children from 20 schools in kabale and kisoro districts in south-western uganda. the main questions it aims to answer are: * how feasible is the introduction of co-administered ivm plus alb in the routine school-based deworming campaign in terms of training, material and processes? * how well do beneficiary communities (pupils, parents) and implementers (teachers, health workers) accept the new treatment scheme and what are potential barriers and enablers for uptake? * what are common implementation-related costs that can inform the methodology to estimate monetary and non-monetary costs as well as performance of the two treatment arms for the future cost-effectiveness analysis? the study employs a cross-sectional mixed-method design (we will collect qualitative and quantitative data) to evaluate the feasibility and acceptability of co-administering ivm and alb versus alb alone in routine school-based mass drug administration. assessments will take place during and after the drug distribution to document the implementation process and evaluate experiences made by the different stakeholders (e.g. children, parents, teachers, health workers): * the implementation activities start with a training of all implementers at district level who will also undergo a pre- and post-training knowledge assessment. * schoolchildren aged 5-14 years will receive a single dose of alb alone or co-administered alb (400mg) and ivm (200µg/kg; as determined by height category on a dose pole) by health workers at school. 1-2 weeks post-distribution a subsample of 19 children per school will be invited to answer to questionnaires administered by social science researchers. * implementers will administer the treatments and document all distribution-related aspects during the campaign under supervision of the routine staff. researchers will conduct additional monitoring and evaluation in order to assure data quality and provide support in performance assessment and cost evaluation. * beneficiaries (parents) and implementers will be asked to take part in focus group discussions and questionnaire interviews one week after the drug distribution.


Eligibility criteria:
* school-aged children (5-14 years) of the selected schools * written informed consent from the participant's parents/caretakers and assent (for children aged 8 years and older) from the participant him/herself or written informed consent from the school teacher (for children attending schools receiving routine albendazole deworming) * no signs of major acute or chronic illness * no known allergy to study medication (i.e. benzimidazoles or ivermectin)

Keywords: soil-transmitted helminths ivermectin deworming albendazole
serum magnesium level administration in severe pre-eclampsia obese pregnancy

Conditions: Severe Pre-eclampsia; Magnesium Level

Summary: comparison of the magnesium level in difference continuous rate in women who were diagnosed severe pre-eclampsia obese

magnesium sulfate is, generally, applied in order to alleviate or to avoid seizures. it can be administered according to many medical approaches. nevertheless, at rajavithi hospital, the recommended administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour (zudpan regimen). the therapeutic index of magnesium is in the range of 4.8-8.4 mg/dl. after that, the level of magnesium sulfate will be evaluated every 4 or 6 hours. at rajavithi hospital, there are a lot of patients having pre-eclampsia symptom and many patients, who were received magnesium sulfate in the treatment, having the level of magnesium sulfate lower than the therapuetic level and needed to increase the maintenance dose to 2.5 grams/hour. therefore, this work aims to studying the amount of magnesium sulfate administered to pregnant woman with pre-eclampsia symptom who possess high body mass index (bmi), especially for bmi greater than or equal to 30 kg/m2.

Eligibility criteria:
inclusion criteria: * pregnancy women who have mbi ≥ 31kg/m2 * pregnancy women who were diagnosed severe pre-eclampsia at gestational age 24 weeks more. * pregnancy women who were diagnosed eclampsia at gestational age 24 weeks more. exclusion criteria: * pregnancy women who were chronic kidney disease or have serum creatinine more than 1.1 mg/dl * pregnancy women who have contraindication to use magnesium sulfate
accuracy of lung ultrasound in the diagnosis of covid19 pneumonia

Conditions: COVID-19; Pneumonia, Viral

Summary: is lung ultrasound really useful in diagnosing covid19? what can be the usefulness of the lung ultrasound in the covid19 epidemic? in the current state of the art, sensitivity, specificity, positive predictive value (ppv) and negative predictive value (npv) of lung ultrasound in the diagnosis of covid-19 are not yet known. alveolar-interstitial lung diseases such as viral pneumonia and ards seems to have a specific ultrasound pattern that distinguishes them from bacterial pneumonia, preferentially represented by b lines, morphological irregularity of the pleural line, and small subpleural consolidations, but they could share these patterns with other pathologies, reducing specificity. in italy, the lung ultrasound represents a consolidated method for the evaluation and management of all patients who come to the er, and what we are sure of is its high sensitivity in identifying pathological patterns. our preliminary data suggest that lung ultrasound is highly reliable not to include but to exclude the diagnosis of covid-19 in patients with respiratory symptoms.

one of the first scientific papers published on the covid-19 epidemic in china showed that patients still asymptomatic or paucisymptomatic, positive for sars-cov-2 on the rt-pcr test, presented chest ct images referring to parenchymal infiltrate with a prevalent appearance at ground-glass compatible with initial covid-19 pneumonia. an ongoing study anticipates that the sensitivity of chest ct is higher than that of the rt-pcr molecular test for sars-cov-2 (performed on the pharyngeal swab or sputum) (50 out of 51, 98%, 95% ci: 90% -100% vs 36 out of 51, 71%, ic95%: 56% -83%) in the early diagnosis of covid-19. recent work seems to shows that lung ultrasound is effective in the clinical evaluation and diagnosis of covid-19 pneumonia. in a previous study, in addition, sensitivity and specificity of the lung ultrasound in the early diagnosis of h1n1 flu pneumonia was 94.1% (32 out of 34) and 84.8% respectively (28 out of 33), with a positive predictive value of 86.5% (32 out of 37) and a negative predictive value of 93.3% (28 out of 30). the concordance between the lung ultrasound findings and the lung lesions found on ct has recently been demonstrated ("lobe-specific" concordance equal to 87%; "lung-specific concordance" equal to 92.5 % for the right lung and 83.6% for the left lung). these data suggest to better explore the diagnostic accuracy of the lung ultrasound in sars-cov-2 infection.

Eligibility criteria:
inclusion criteria: * fever and/or * cough and/or * dyspnoea exclusion criteria: * no one

Keywords: covid-19 lung ultrasound pocus
treatment of uncomplicated childhood malaria in tanzania by artemether+lumefantrine - efficacy and genotyping

Conditions: Malaria

Summary: the purpose of this explorative clinical trial is to study parasite population dynamics, diversity and clearance kinetics of plasmodium falciparum as well as determination of the molecular mechanisms associated with drug resistance during the early phase of artemether-lumefantrine treatment when the drug intake is either accompanied with or without intake of fatty food. the hypothesis is that intake of fatty food together with artemether-lumefantrine will enhance parasite clearance and thereby decrease the risk of early selection of genetic markers related to drug resistance. the study population is children aged 1-10 years with uncomplicated malaria in bagamoyo district, tanzania. enrolled children will be randomly allocated to either intake of a fatty meal or not together with the study drug. artemether-lumefantrine will be given twice daily for 3 days in standard doses according to bodyweight. study participants will be admitted during the study period (3 days)to allow close supervision and detailed blood sampling.


Eligibility criteria:
inclusion criteria: * age 1-10 years * presence of asexual p. falciparum parasitaemia of 2000-200 000/μl * no general danger signs or severe malaria present * haemoglobin ≥70 g/l * history of fever within 24 hours or axillary temperature ≥ 37.5cº * no other cause of fever is detectable * no severe malnutrition * guardian/patient has understood the procedures of the study and willing to participate exclusion criteria: * not able to drink or breastfeed * vomiting everything * recent history of convulsions * lethargic or unconscious * unable to sit or stand (as appropriate for age) * history of allergy to test drugs * history of intake of any drugs other than paracetamol and aspirin within 3 days * symptoms/signs of severe malaria
phase 2 trial of td-6424 (telavancin) versus standard therapy for complicated gram positive skin and skin structure infections (gram positive csssi)

Conditions: Infections, Gram-positive Bacterial

Summary: serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. this study will measure how well td-6424 (telavancin) can control infections and whether the drug is safe to give to patients.


Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed gram positive organism * major abscess requiring surgical incision and drainage * infected burn (see exclusion criteria for important qualifications) * deep/extensive cellulitis * infected ulcer (see exclusion criteria for important qualifications) * wound infection * patients must be expected to require at least 4 days of intravenous (iv) antibiotic treatment exclusion criteria: * previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for \> 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days) * burns involving \> 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis

Keywords: abscess burns cellulitis ulcer wound infections
study of subcutaneous risankizumab injection compared to oral apremilast tablets to assess change in disease activity and adverse events in adult participants with moderate plaque psoriasis who are candidates for systemic therapy

Conditions: Psoriasis

Summary: psoriasis (pso) is a chronic disease characterized by marked inflammation of the skin that results in thick, red, scaly plaques. this study will assess how safe and effective risankizumab is compared to apremilast in adult participants with moderate plaque psoriasis. adverse events and change in disease symptoms will be monitored. risankizumab (skyrizi) and apremilast are approved drugs for the treatment of moderate to severe pso. approximately 330 participants with moderate plaque psoriasis (pso) will be enrolled across approximately 55 sites globally. the study has 2 periods : period a from baseline to week 16, and period b, from week 16 to week 52. in period a, participants will be randomly placed into 2 groups to receive either subcutaneous risankizumab or oral apremilast for 16 weeks. in period b, participants who received apremilast in period a will again be randomly assigned to 1 of the 2 groups to receive either risankizumab or apremilast for 36 weeks. at weeks 28 and 40, participants considered non-responders to apremilast based on their psoriasis score will be offered to receive risankizumab. there may be a higher burden for participants in this study compared to usual standard of care. participants will attend regular visits per routine clinical practice. the effect of the treatment will be checked by medical assessments, checking for side effects, and questionnaires.


Eligibility criteria:
inclusion criteria: - candidates for systemic therapy with moderate chronic plaque psoriasis (pso) (with or without psoriatic arthritis) at screening and baseline for at least 6 months prior to baseline defined as: * body surface area (bsa) \>= 10% and \<= 15%; and * psoriasis area and severity index (pasi) \>= 12; and * static physician global assessment (spga) = 3 (moderate) based on a 5-point scale (0 to 4). exclusion criteria: * participant has any form of pso other than chronic plaque pso (e.g., pustular pso, palmoplantar pustulosis, acrodermatitis of hallopeau, erythrodermic, or guttate pso). * history of current drug-induced pso or a drug-induced exacerbation of pre-existing psoriasis. * history of active ongoing inflammatory skin diseases other than pso and psoriatic arthritis that could interfere with the assessment of pso (e.g., hyperkeratotic eczema). * prior exposure to risankizumab or apremilast.

Keywords: psoriasis plaque psoriasis risankizumab abbv-066 skyrizi apremilast
pharmacovigilance and patient compliance in hypertensive patients

Conditions: Hypertension

Summary: study to confirm the safety profile of telmisartan (benefit-risk ratio) under normal conditions of use after market launch and to supplement the present data on the safety of telmisartan. furthermore to assess effectiveness of a single dose of telmisartan per day to control blood pressure for 24 hours, especially during the last few hours of the dosage interval. additionally to evaluate compliance with treatment, as an indirect measurement, and to confirm the efficacy and possible risks associated with treatment.


Eligibility criteria:
inclusion criteria: - patients of either sex over the age of 18 years suffering from non-secondary essential hypertension with values of at least 90 mmhg (diastolic) and 140 mmhg (systolic) exclusion criteria: - corresponding to the contraindications listed in the summary of product characteristics of the drug
the effect of vitamin d supplementation on disease activity markers in systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) is a chronic multi-system inflammatory autoimmune disease. vitamin d has potent immunomodulatory properties that have promoted its potential use in the treatment of autoimmune conditions, including sle. we assessed vitamin d status in sle patients and determined alterations in inflammatory, hemostatic markers as well as disease activity before and after vitamin d supplementation. 248 sle patients were enrolled in this randomized placebo-controlled study. patients were randomized 2:1 to receive either oral cholecalciferol 2000 iu/day or placebo for 12 months. outcome measures included assessment of alterations in levels of il-1, il-6, il-18, tnf-alpha, anti-dsdna, ana, fibrinogen and von willebrand factor (vwf) before and after 12 months supplementation. disease activity was measured by the sledai. vitamin d levels were measured by liaison immunoassay; (normal 30-100ng/ml). serum levels between 10-30 ng/ml were classified as vitamin d insufficiency, and levels \< 10 ng/ml as vitamin d deficiency.the mean 25(oh) d level at baseline was 19.8 ng/ml in patients compared to 28.7 ng/ml in controls.


Eligibility criteria:
inclusion criteria: * premenopausal women and males of the same body mass index and ethnicity exclusion criteria: patients with: * other inflammatory disorders, * hepatic disease * renal disease * malignant disease.

Keywords: sle disease activity markers vitamin d
comparison of the combination of fenofibrate and 20 mg simvastatin versus 40 mg simvastatin monotherapy

Conditions: Hyperlipidemia

Summary: mixed or combined hyperlipidemia is a common metabolic disorder characterized by both hypercholesterolemia and hypertriglyceridemia. statins and fibrates have complementary mechanisms and can be coadministered to patients with mixed hyperlipidemia. the overall objective of the study is to evaluate the efficacy and safety of combining fenofibrate and simvastatin in patients with mixed hyperlipidemia at risk of cardiovascular diseases.


Eligibility criteria:
inclusion criteria: * mixed dyslipidemia exclusion criteria: * known hypersensitivity to fenofibrate or simvastatin * pregnant or lactating women * contra-indication to fenofibrate or simvastatin * unstable or severe cardiac disease

Keywords: hyperlipidemia combined, efficacy combination fenofibrate simvastatin
a study of pegasys monotherapy in patients with chronic hepatitis b who have participated in previous studies

Conditions: Hepatitis B, Chronic

Summary: in this open-label multicenter study the long-term effect of pegasys monotherapy on pharmacodynamic hbv-related markers will be investigated in patients with chronic hepatitis b. eligible patients will have completed treatment on another donor protocol (e.g. pp22512) and will receive pegasys at an appropriate dose based on the standard of care (180mcg sc once weekly) for up to 48 weeks. target sample size is \<100.


Eligibility criteria:
inclusion criteria: * adult patients \>/=18 years of age * previous participation in other donor protocol * chronic hepatitis b * no other anti-hbv treatment after completion of previous donor protocol * female patients and female partners of male patients must use at least two methods of contraception until 28 days after completion of study exclusion criteria: * hepatic decompensation (child-pugh class b and c) * antiviral, antineoplastic or immunomodulatory treatment * evidence of alcohol and/or drug abuse
nephrotoxicity associated to parenchymal clamping during partial nephrectomy using a microdialysis technique

Conditions: Nephrectomy; Kidney Cancer; Microdialysis

Summary: surgery plays a central role in kidney cancer management being the only therapy that offers the possibility of healing the patients. currently, the partial nephrectomy is a standard technique because it meets the principle of nephron sparing surgery. a partial nephrectomy requires a control of the renal blood flow using a clamp, which can be parenchymal or vascular (pedicular). in france, most of the centers use pedicular clamping. it is well established that this technique results in warm ischemia of the entire healthy parenchyma and can lead to permanent kidney damages. currently, no study evaluated the impact of parenchymal clamping on the healthy parenchyma. the aim of the investigators study is to evaluate the nephrotoxicity of the healthy parenchyma due to parenchymal clamping during partial nephrectomy. this assessment will be done through a microdialysis technique. the microdialysis probe is directly implanted in the healthy unclamped parenchyma and will allow us to measure in real time, during the surgery, the biological changes related to anaerobic metabolism of renal interstitial space. all those measures will be completed by urinary and plasmatic assessments. oxidative stress will be assessed using four markers of tubular viability : interleukin 18 (il18), kidney injury molecule-1 (kim-1), neutrophil gelatinase-associated lipocalin (ngal) and cystatin c and four parameters of anaerobic metabolism : lactate, pyruvate, glycerol and glucose. this is a prospective pilot study limited to 10 patients included over 12 months. depending on the results, it will be further developed by a second study comparing parenchymal with pedicle clamping.


Eligibility criteria:
inclusion criteria: * patients referred to the urological surgery department with an indication of partial nephrectomy * patients with a renal lesion classified t1 (≤7cm) or for t2 eligible to a partial nephrectomy and having an possibility to benefit from a parenchymal clamping (decided on preoperative imaging) exclusion criteria: * patient with a chronic kidney disease (functional or structural renal abnormality evolving for more than three months and glomerular filtration rate \<60 ml/min) * patient carrying a renal lesion classified t1 but too close to the renal pedicle or not accessible for a parenchymal clamping * patients in whom tumor removal requires ice cooling or kidney pedicular clamping

Keywords: parenchymal clamping microdialysis technique partial nephrectomy
effect of intra-articular injection on temporomandibular joint dysfunction

Conditions: Temporomandibular Joint Dysfunction

Summary: the goal of this clinical trial is to study about the clinical effect of intra-articular injection on temporomandibular joint dysfunction the main question it aims to answer is: • can intra-articular injection help improve the temporomandibular joint dysfunction participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. the experimental group will be given intra-articular injection additionally, the study lasts 15 days for each patient. researchers will compare the assessments between the two groups to see if intra-articular injection can help improve the temporomandibular joint dysfunction

the background of temporomandibular joint dysfunction is that it is one of the common diseases in the oral and maxillofacial region, and it is the most common among temporomandibular joint diseases. it is more prevalent in young adults, with the highest prevalence rate at 20-30 years old. the goal of this clinical trial is to study about the clinical effect of intra-articular injection on temporomandibular joint dysfunction the main question it aims to answer is: • can intra-articular injection help improve the temporomandibular joint dysfunction participants will be randomly assigned into the experimental group and the control group, all under comprehensive treatment. the experimental group will be given intra-articular injection additionally, the study lasts 15 days for each patient. researchers will compare the assessments between the two groups to see if intra-articular injection can help improve the temporomandibular joint dysfunction

Eligibility criteria:
inclusion criteria: * presence of significant temporomandibular disorder clinical symptoms. * meeting the diagnostic criteria for temporomandibular joint dysfunction and confirmed by x-ray examination. * patients voluntarily participate in this study and provide signed informed consent. * normal cognitive function exclusion criteria: * rheumatic, rheumatoid, or other severe systemic diseases. * infectious temporomandibular joint arthritis or joint tumors. * individuals who have recently received joint injection treatment or photodynamic therapy.